Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- To compare the pattern of bacterial gas excretion in breath among Veterans with FD vs. controls using LBT
研究概览
简要总结
The prevalence of functional dyspepsia (FD) is estimated to be 15% of the adult population. FD is commonly described as a condition of chronic abdominal discomfort localized to the upper abdomen. Postprandial bloating, pain, nausea, vomiting, belching, and early satiety are common symptoms of the FD patient. FD is defined by >12 weeks of symptoms, which need not be consecutive, within the preceding year consisting of a) persistent or recurrent dyspepsia and b) an absence of organic disease after a gastrointestinal endoscopy or x-ray series. FD is therefore considered a disorder of function because no mucosal pathology is seen in these patients, as in patients with other functional disorders such as irritable bowel syndrome (IBS) and fibromyalgia (FM). There is a remarkable degree of overlap among these three disorders. These 3 disorders share the finding of hypersensitivity and the symptom of postprandial bloating to suggest the possibility of a common origin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have FD based on the most recent Umbrella criteria of one or more of: a. bothersome postprandial fullness, b. early satiation, c. epigastric pain, d. epigastric burning
- •No evidence of organic disease (including H. pylori detected at time of endoscopy) that is likely to explain the symptoms
- •Criteria must be fulfilled for the last 3 months with symptom onset at least 6 months before the diagnosis
- •The physical exam, routine blood tests including CBC, chemistry panel and liver tests, upper gastrointestinal endoscopy and 24h pH study must be normal
排除标准
- •History of IBS,rheumatoid arthritis,H. Pylori infection,lupus,peptic ulcer, cirrhosis,diabetes, HIV or TB
- •Inflammatory bowel disease
- •Bowel Resection (including gastric, small bowel or colon; gallbladder surgery or appendectomy are NOT exclusion criteria)
- •Anti/pro-biotics last 3 months
- •Previous LBT (Lactulose Breath Test)
- •Narcotic Dependence
- •Pregnancy
- •Control subjects will be excluded if they have symptoms of heartburn, retrosternal chest pain, chronic cough, nausea or regurgitation suggestive of gastroesophageal reflux disease
研究组 & 干预措施
Control Participants
干预措施: Lactulose Breath Test (Procedure)
FD Participants
干预措施: Rifaximin (Drug)
FD Participants
干预措施: Lactulose Breath Test (Procedure)
FD (Placebo) Participants
干预措施: Placebo (Drug)
结局指标
主要结局
To compare the pattern of bacterial gas excretion in breath among Veterans with FD vs. controls using LBT
时间窗: every 15 minutes for 180 minutes
次要结局
- The investigators will determine the relationship between SIBO in FD patients using randomized antibiotic treatment(2 weeks)
研究者
Henry C. Lin, MD
Henry C. Lin, MD
New Mexico VA Healthcare System
